Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections

• Conditions: Infective Endocarditis; Pneumonia, Bacterial; Sepsis
• Interventions: Diagnostic Test: Bood leukocyte subsets; Diagnostic Test: The cholesterol content of the cell membrane of T-cells and monocytes

• Registration Number: NCT04178915
• Lead Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

Brief Summary

Current study evaluates the relationship between cell immunity and lipid transport systems in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis) in order to develop new methods for predicting the course and outcome of severe bacterial infections.

Detailed Description

* To study the state of the immune system in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis): spontaneous and stimulated production of reactive oxygen species by blood neutrophils; spontaneous necroptosis, apoptosis and pyroptosis of neutrophils; the content of blood leukocyte subpopulations.

* Assess the clinical, biochemical status, state of the lipid transport system of patients with severe bacterial infections (in the model of pneumonia, infective endocarditis, sepsis), including determination of the cholesterol content in the cell membrane of T-cells and monocytes.

* To develop a method for predicting an unfavorable course and an algorithm for the treatment (immunocorrection) of severe bacterial infections (on the model of pneumonia, infectious endocarditis, sepsis) based on the determination of the clinical and immunological status, indicators of the lipid transport system and dysmetabolic disorders, and propose a correction method for the treatment of these diseases, supplementing existing clinical protocols (preparations of immunoglobulins, lipids for parenteral nutrition, possibly PCSK9 inhibitors).

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• community-acquired pneumonia, severe course (according to IDSA / ATs criteria) and / or sepsis with different localization of the primary focus (SOFA> 2);
• the patient's ability to comply with the instructions of the research doctor and follow the procedures required by the test protocol;
• informed consent.

Exclusion Criteria

• acute and chronic heart failure;
• renal failure;
• acute and chronic liver failure;
• taking medications of the statin group during the last month before the study;
• diabetes in the stage of clinical and metabolic decompensation;
• acute and chronic leukemia, severe anemia;
• pregnancy or lactation;
• HIV infection;
• drug addiction;
• immunosuppressive therapy;
• malignant neoplasms over the past 5 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with severe bacterial infections	The cholesterol content of the cell membrane of T-cells and monocytes	-
Patients with severe bacterial infections	Bood leukocyte subsets	-

Primary Outcome Measures

Name	Time	Method
Survival rate	1 month

Trial Locations

Locations (1)

The Republican Research and Practical Center for Epidemiology and Microbiology; 🇧🇾 Minsk, Belarus